SH-1028

Phase 3Small molecule

NNanjing Sanhome Pharmaceutical, Co., Ltd.

SH-1028 is one of 23 small molecule programs targeting Adjuvant Therapy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Adjuvant TherapyRecruiting

Adjuvant TherapyPhase 3

Recruiting

Competition

Competitive Landscape

25 competitors in Adjuvant Therapy

#DrugCompanyPhaseTrials

Cialis

Eli Lilly

Phase 3

1 2

Verzenio

Eli Lilly

Phase 3

1 3

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

3 4

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

2 5

Conmana

BBetta Pharmaceuticals Co., Ltd.

Phase 3

2 6

Ensacove

XXcovery Holdings, Inc.

Phase 3

1 7

Herceptin

OOrganon and Co

Phase 3

1 8

Beyfortus

BeiGene

Phase 2

2 9

Imfinzi

AstraZeneca

Phase 2

2 10

Opdivo

Bristol-Myers Squibb

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2031

Phase 3Recruiting

Adjuvant Therapy

NCT06080776

Clinical

Trials by Indication[1]

Advanced NSCLC1 trial

Safety, Tolerability and Pharmacokinetics of SH-1028 in Patients With Advanced NSCLC

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 1·NCT03603262·85 enrolled

Non-Small Cell Lung Cancer1 trial

A Study of SH-1028 Tablets Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 3·NCT04239833·240 enrolled

Adjuvant Therapy1 trial

SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations

Recruiting·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 3·NCT06080776·242 enrolled

Absorption1 trial

The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers

Completed·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 1·NCT04810533·6 enrolled

Fed1 trial

Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 1·NCT03973632·16 enrolled

3 more indications

Tics1 trial

The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SH-1028

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 1·NCT04808648·40 enrolled

Advanced Solid Cancer1 trial

Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 1·NCT03618043·14 enrolled

Locally Advanced or Metastatic NSCLC1 trial

A Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC

Unknown status·NNanjing Sanhome Pharmaceutical, Co., Ltd.·Phase 2·NCT03823807·300 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for SH-1028. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SH-1028 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SH-1028. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Nanjing Sanhome Pharmaceutical, Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNanjing Sanhome Pharmaceutical, Co., Ltd.

SH-1028

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2031

Trials by Indication[1]

Advanced NSCLC1 trial

Non-Small Cell Lung Cancer1 trial

Adjuvant Therapy1 trial

Absorption1 trial

Fed1 trial

Tics1 trial

Advanced Solid Cancer1 trial

Locally Advanced or Metastatic NSCLC1 trial

References

Drug Info

Quick Facts

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